Effect of Amlodipine on the Lipid Profile of Newly Diagnosed Hypertensive Patients

NCT ID: NCT05467384

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2017-06-30

Brief Summary

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In this study, Amlodipine has been used to study its effects in newly diagnosed hypertensive patients.

Detailed Description

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The incidence of hypertension is on the rise in developing countries like Pakistan. Different medications are used to decrease blood pressure with Amlodipine as one of the first-line drugs. It was proposed that due to interaction with calcium and thus luminal cholecystokinin releasing factor; Amlodipine might increase the cholesterol level and thus cause dyslipidemia.

Objective: In this regard, this study was conducted to look into the effects of Amlodipine in newly diagnosed cases of hypertension that had received no medication previously.

Methodology: Experimental study with a healthy control group with the sample size calculated out to be 80, comprising of an equal number of enrolment into case and control groups.

Conditions

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Hypercholesterolemia Hypertension Cholesterol Deposition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Case with healthy control
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Newly Diagnosed Hypertensive patients

These are the patients that have been clearly diagnosed with diabetes for the first time.

Group Type EXPERIMENTAL

Amlodipine

Intervention Type DRUG

5mg/day in two divided doses

Healthy Controls

Healthy Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Amlodipine

5mg/day in two divided doses

Intervention Type DRUG

Other Intervention Names

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Norvasc

Eligibility Criteria

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Inclusion Criteria

1. Normal lipid profile.

Exclusion Criteria

1\) Any other major illness.


1\) Any major illness.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Khyber Medical University Peshawar

OTHER

Sponsor Role collaborator

Ayub Teaching Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shahid ali shah

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shahid A Shah, BDS, MPhil

Role: PRINCIPAL_INVESTIGATOR

Faculté d'Odontologie, Université de Montpellier

References

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James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427.

Reference Type BACKGROUND
PMID: 24352797 (View on PubMed)

Abebe SM, Berhane Y, Worku A, Getachew A. Prevalence and associated factors of hypertension: a crossectional community based study in northwest ethiopia. PLoS One. 2015 Apr 24;10(4):e0125210. doi: 10.1371/journal.pone.0125210. eCollection 2015.

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Mancia G, De Backer G, Dominiczak A, Cifkova R, Fagard R, Germano G, Grassi G, Heagerty AM, Kjeldsen SE, Laurent S, Narkiewicz K, Ruilope L, Rynkiewicz A, Schmieder RE, Boudier HA, Zanchetti A, Vahanian A, Camm J, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Erdine S, Kiowski W, Agabiti-Rosei E, Ambrosioni E, Lindholm LH, Viigimaa M, Adamopoulos S, Agabiti-Rosei E, Ambrosioni E, Bertomeu V, Clement D, Erdine S, Farsang C, Gaita D, Lip G, Mallion JM, Manolis AJ, Nilsson PM, O'Brien E, Ponikowski P, Redon J, Ruschitzka F, Tamargo J, van Zwieten P, Waeber B, Williams B; Management of Arterial Hypertension of the European Society of Hypertension; European Society of Cardiology. 2007 Guidelines for the Management of Arterial Hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2007 Jun;25(6):1105-87. doi: 10.1097/HJH.0b013e3281fc975a. No abstract available.

Reference Type BACKGROUND
PMID: 17563527 (View on PubMed)

Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.

Reference Type BACKGROUND
PMID: 12748199 (View on PubMed)

Ruilope LM, Burnier M, Muszbek N, Brown RE, Keskinaslan A, Ferber P, Harms G. Public health value of fixed-dose combinations in hypertension. Blood Press Suppl. 2008 Jun;1:5-14.

Reference Type BACKGROUND
PMID: 18705530 (View on PubMed)

Saleem F, Hassali AA, Shafie AA. Hypertension in Pakistan: time to take some serious action. Br J Gen Pract. 2010 Jun;60(575):449-50. doi: 10.3399/bjgp10X502182. No abstract available.

Reference Type BACKGROUND
PMID: 20529498 (View on PubMed)

Hashmi SK, Afridi MB, Abbas K, Sajwani RA, Saleheen D, Frossard PM, Ishaq M, Ambreen A, Ahmad U. Factors associated with adherence to anti-hypertensive treatment in Pakistan. PLoS One. 2007 Mar 14;2(3):e280. doi: 10.1371/journal.pone.0000280.

Reference Type BACKGROUND
PMID: 17356691 (View on PubMed)

Johnson LK, Hofso D, Aasheim ET, Tanbo T, Holven KB, Andersen LF, Roislien J, Hjelmesaeth J. Impact of gender on vitamin D deficiency in morbidly obese patients: a cross-sectional study. Eur J Clin Nutr. 2012 Jan;66(1):83-90. doi: 10.1038/ejcn.2011.140. Epub 2011 Jul 27.

Reference Type BACKGROUND
PMID: 21792214 (View on PubMed)

van Ballegooijen AJ, Cepelis A, Visser M, Brouwer IA, van Schoor NM, Beulens JW. Joint Association of Low Vitamin D and Vitamin K Status With Blood Pressure and Hypertension. Hypertension. 2017 Jun;69(6):1165-1172. doi: 10.1161/HYPERTENSIONAHA.116.08869. Epub 2017 Apr 10.

Reference Type BACKGROUND
PMID: 28396533 (View on PubMed)

Akoko BM, Fon PN, Ngu RC, Ngu KB. Knowledge of Hypertension and Compliance with Therapy Among Hypertensive Patients in the Bamenda Health District of Cameroon: A Cross-sectional Study. Cardiol Ther. 2017 Jun;6(1):53-67. doi: 10.1007/s40119-016-0079-x. Epub 2016 Dec 29.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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Lauro M, Carbone C, Auditore R, Musumeci T, Santagati N, Aquino R, et al. A new inclusion complex of amlodipine besylate and soluble β-cyclodextrin polymer preparation, characterization and dissolution profile. Journal of Inclusion Phenomena and Macrocyclic Chemistry. 2013;76(1-2)19-28.

Reference Type BACKGROUND

Other Identifiers

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sashah0002

Identifier Type: -

Identifier Source: org_study_id

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